Conduct↦Documents↦Required Documents↦Oversight Documentation
What is it? Why is it important?
During study conduct, SP-INV and Site-INV are responsible to maintain ongoign study oversight.
Study oversight is achieved through tracking study activities, documented in study documents/records, such as:
- Patient file and ICF: compliance with informed consent procedures
- Study logs: the delegation of study responsibilities, study trainings, participant recruitment
- Source data / study database: compliance with data entry requirements
- Note to file: documentation of non-compliance
- Monitoring / Audit report: documentation of study compliance
- SAE and SUSAR forms: compliance with safety assessment and reporting requirements
- Amendments: documentation of changes to the study protocol, ICF, PIS, IB
- Risk-register: risk evaluation and the implementation of risk control-measures
- Staff CV / job description: study staff qualification and responsibilities
- Handling Investigational product (IMP/IMD): orders-, inventory-, shipments-, storage conditions documents
- Communication: with partners, participants, study sites
- Handling of Biological Material: sample workflow documents
- Update reports: study safety and progress
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The SP-INV and Site-INV can delegate study tasks to qualified staff. However, overall study responsibility remains with the SP-INV and Site-INV, respectively.
What do I need to do?
As a SP-INV or Site-INV: implement study oversight and ensure:
- Ongoing compliance with the study protocol and regulatory requirements (e.g. ICH GCP, ISO 14155, Swiss Laws)
- The rights and safety of study participant are protected
- The quality of study data is guaranteed
Aspects to address include to:
- Check that all study documentation is current and correct
- Regularly review the TMF or ISF to ensure all essential documents/records are filed
- Ensure data entry into the study CRF is done without delay
- Ensure monitoring/audit findings are quickly addressed and resolved
- Identify risks to study quality and patient right/safety and implement risk control-measures
- Address non-compliance issues and means needed to prevent reoccurrence
A good way to retain study oversight is to plan regular:
- Team meetings, where problems are identified and corrective measures are discussed and implemented
- Audits to assess internal study procedures and partners (e.g. data management-, statistic-, pharmacy-, laboratory services)
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Document the meeting in a protocol and include:
- Identified problems or issues
- The implementation of corrective and or preventative measures, and the resolution of pending issues
- Adaptations regarding study processes and management
Documented protocol meetings:
- Are important reference documents for study staff, including meeting absentees
- Provide good evidence of study oversight in the event of an audit or inspection by RA (e.g. Swissmedic)
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
ICH GCP E6(R3) – see in particular guidelines
- Glossary: Definition essential records
- II ICH GCP principles Nr. 10 Documentation of study roles and responsibilities
- 2.5 Compliance with protocol
- 2.3. Investigator responsibilities and delegation of trial-activities
- 3.3 Sponsor allocation of activities
- 3.9 Sponsor Oversight
- 3.12 Noncompliance
- 3.13 Safety assessment and reporting
- Appendix C. Essential records for the conduct of a clinical trial
ISO14155:2020 Medical devices - see in particular section (access liable to cost)
- 10 Responsibilities of the principle investigator